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Research that Holds Water

July 8, 2013 10:15 am | by The University of Akron | News | Comments

Dr. Jie Zheng and Dr. Robert Weiss are among the most recent to contribute to the growing research of hydrogels, the gelatinous substance that, because of its toughness and plasticity, has several biomedical applications, including cartilage repair, implants for minimally invasive surgery and drug delivery.

1st-in-man trial for Dallen Medical's Compressyn band device

July 8, 2013 9:59 am | by Mass Device | News | Comments

Early-stage device company Dallen Medical announced a 1st-in-man study of its Compressyn band, a breast-plate wire closure device designed to help stabilize patients after open heart surgery. After the sternum is cracked during open-heart surgery, patients require specialized wires to hold the cavity together.

Life Care Medical Devices Signs Exclusive Agreement with M.E.D. Surgical for the Distribution in Ireland of its Proprietary Keyhole Cup@ Laparoscopic Access Device

July 8, 2013 8:45 am | by The Associated Press | News | Comments

Life Care Medical Devices Ltd., (OTC BB: LCMD), a development stage medical device company today announced that Life Care Medical Devices, Ltd, Ireland signed an exclusive agreement with M.E.D. Surgical, a subsidiary of Sisk Healthcare for the distribution of the Company's Keyhole Cup@ ...

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Baxano Surgical pays $6M to settle federal healthcare fraud beef

July 8, 2013 7:59 am | by Mass Device | News | Comments

North Carolina medical device maker Baxano Surgical Inc. (NSDQ:BAXS) agreed to pay $6 million to close a Justice Dept. probe initiated nearly 2 years ago. The definitive settlement consummates a tentative agreement the spinal device company forged with federal regulators in December 2012, according to a Baxano Surgical statement.

Medtronic prevails in bone mill antitrust suit filed by Lenox MacLaren Surgical

July 3, 2013 11:21 am | by Mass Device | News | Comments

Medtronic (NYSE:MDT) prevailed in an antitrust lawsuit filed over a bone mill made by Lenox MacLaren Surgical, with a federal judge ruling that Lenox misrepresented the size of the bone mill market and failed to adequately market its own device.

Blaze Biosciences ropes in $8.1M for tumor targeting "paint"

July 3, 2013 7:59 am | by Mass Device | News | Comments

Blaze Biosciences is more than halfway to a targeted $15 million in a Series B round to fund its Tumor Paint, a surgical tool that visually distinguishes solid tumor cells from healthy cells. Founded in 2010, the Seattle, Wash.-based Blaze Biosciences has roped in about $8.1 million since opening the round in June.

ArthroCare pays $45M for ENTrigue Surgical, buys stake in Ortho-Space

July 2, 2013 3:36 pm | by Mass Device | News | Comments

ArthroCare (NSDQ:ARTC) said it closed its $45 million acquisition of ENTrigue Surgical and bought a nearly 20% stake in Israeli medical device company Ortho-Space. The deal price for ENTrigue, which makes a device to treat chronic sinusitis, includes "contingent consideration" pegged to sales growth milestones, according to a press release.

More hospitals settle Medtronic's Kyphon Medicare fraud cases

July 2, 2013 12:58 pm | by Mass Device | News | Comments

Some 55 U.S. hospitals agreed to pay a total of $34 million to settle U.S. Justice Dept. charges that they overcharged Medicare for Medtronic's (NYSE:MDT)'s kyphoplasty spine procedure, acquired in the $3.9 billion buyout of Kyphon in 2007, the Justice Dept. said today.

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Integra LifeSciences recall affects Medtronic's Infuse kits

July 2, 2013 12:53 pm | by Mass Device | News | Comments

Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.  

SpineGuard Obtains Regulatory Clearance to Sell Cannulated PediGuard® in Mexico

July 2, 2013 12:00 pm | by Business Wire | News | Comments

SpineGuard announced today that it has obtained regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its Cannulated PediGuard® device in Mexico. SpineGuard has previously received clearance for its Classic PediGuard device, and over 50 Mexican spine surgeons have been trained on the technology.

Identifying Patients Who Can Skip ACL Reconstruction

July 2, 2013 10:19 am | by Hospital for Special Surgery | News | Comments

A study by researchers at Hospital for Special Surgery has provided the first evidence that the shape of a person's knee could be a factor in the decision of whether a patient should undergo anterior cruciate ligament reconstruction after an ACL tear.

ArthroCare Announces Acquisition of ENTrigue Surgical, Inc.

July 2, 2013 9:05 am | by Business Wire | News | Comments

ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, today announced that it has completed the acquisition of ENTrigue Surgical, Inc., a privately held Delaware corporation (“ENTrigue”), in an all cash transaction.

Dallen Medical Initiates “First-in-Man” Clinical Study of its Compressyn™ Band Sternal Closure Device

July 2, 2013 8:00 am | by Business Wire | News | Comments

Dallen Medical, an emerging medical device company, announced today that the first three patients have been treated using its proprietary Compressyn™ Band sternal closure device. The first Compressyn device used for stabilization and rigid fixation following open heart procedures was performed by Dr. Joseph Wilson of Eisenhower Medical Center.

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ZOLL Announces Acquisition of the Assets of CoAxia

July 1, 2013 11:19 am | by Business Wire | News | Comments

ZOLL Medical Corporation has purchased the assets of CoAxia, an early revenue stage medical device company that provides catheter-based perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from vasospasm, following subarachnoid hemorrhage.

Poland - a New Player in Medical Tourism Sector

June 28, 2013 9:00 am | by PR Newswire | News | Comments

Is it possible, that in 2-3 years Brits, Germans, Scandinavians, and Russians will undergo cancer treatment, orthopaedic, or cardiac surgery procedures in Polish medical facilities more often? Treat teeth and get implants in dental clinics; take a cure in Polish sanatoriums?

New Red Blood Cell Simulator Invented At Queen Mary

June 27, 2013 3:58 pm | by Queen Mary, University of London | News | Comments

Engineers from Queen Mary, University of London have developed the most precise computer simulation of how red blood cells might travel around the body to help doctors treat people with serious circulatory problems. Understanding how damaged red blood cells might interact with each other or their neighboring cells could be useful in realizing blood flow in patients who are diabetic or have had surgery to address circulation complications.

Device Designed to Avert Repeated Breast Cancer Surgeries

June 27, 2013 12:15 pm | by Johns Hopkins | Videos | Comments

When a breast tumor is detected, many women opt to have a lumpectomy, which is surgery designed to remove the diseased tissue while preserving the breast. But during this procedure, doctors cannot learn right away whether all of the cancerous tissue has been removed, with no microscopic signs that cancer cells were left behind.

Johns Hopkins Students’ Device Aims to Avert Repeated Breast Cancer Surgeries

June 27, 2013 11:57 am | by Johns Hopkins | News | Comments

To reduce the need for second surgeries, four Johns Hopkins graduate students have designed a device to allow pathologists to quickly inspect excised breast tissue within 20 minutes, while the patient is still in the operating room. If this inspection indicates that the tumor was not fully removed, additional tissue can then be removed during the same operation.

Spinning Up Antibacterial Silver on Glass

June 27, 2013 10:30 am | by Inderscience Publishers | News | Comments

The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.

Robotic Surgical Systems on the Ropes

June 26, 2013 2:16 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

There have been reports of issues and lawsuits from procedures gone wrong when a robotic surgical system was used. Yes, there have been issues and they do need to be addressed, however, abandoning robotic surgical systems is not the answer. In fact, it would be a complete mistake.

PMA Final Decisions for April 2013

June 26, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

CryoLife Receives Conditional IDE Approval to Begin Clinical Trials for PerClot@ in the U.S.

June 21, 2013 8:34 am | by The Associated Press | News | Comments

CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA).

Class I Medical Device Recall: Medtronic Xomed, Inc., NIM Trivantage EMG Endotracheal Tube

June 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death.

FDA Approves New Silicone Breast Implant from J&J

June 20, 2013 4:53 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration said last Friday it approved a next-generation silicone breast implant from Johnson & Johnson unit Mentor. The company's MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants.

Realistic 3D Tumour Through Tissue Engineering Using Silk Scaffolds

June 20, 2013 9:47 am | by National University of Singapore | News | Comments

A team of NUS researchers from the Departments of Bioengineering and Orthopaedic Surgery has developed a highly realistic three-dimensional (3D) tumour model. As it replicates the conditions in the body, it is able to track the effectiveness and progress of drug therapy.

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